4.

A risk assessment on the active substance(s) present in the biocidal product is always required. This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation. Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.